PROtocol for Coxsackievirus VaccinE in Healthy VoluNTteers

Provention Bio, Inc.32 enrolled

Overview

Phase 1, first-in-human, randomized, double-blind, placebo-controlled, multiple-dose-escalation study to evaluate the safety, tolerability and immunogenicity of PRV-101, a coxsackie virus B vaccine, in healthy volunteers.

Thirty two healthy adult subjects will be enrolled into 2 dose cohorts (low-dose and high-dose cohorts, 16 subjects per cohort) and will be randomized in a double-blind manner to PRV-101 or placebo in a 3:1 ratio. Each subject will receive up to 3 administrations of the study drug (PRV-101 or placebo) at 4-week intervals and will be followed for 24 weeks after the final dose. Each cohort will start with a sentinel dosing group (2 subjects). Cohort 2 will commence after safety data from the first 2 doses from all Cohort 1 participants are reviewed.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Viral; Infection, Coxsackie(Virus)

Interventions

PRV-101BIOLOGICAL

Coxsackie Virus B vaccine

PlaceboOTHER

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy adults, males and females, ages 18 to 45 yrs, with BMI 19 to 30 kg/m2 * Women of childbearing potential must have negative pregnancy test and agree to use an acceptable method of highly effective contraceptive * Men must either have a vasectomy or agree to use highly effective contraception Exclusion Criteria: * Prior or current clinically significant medical illness or disorder * Has celiac disease or type 1 diabetes or related autoantibodies * Has active acute or chronic/latent infection, or history of recent serious infection * Recent acute illness or recent major illness, hospitalization or surgery * Recent history of alcohol or drug abuse * Received an experimental antibody or biologic therapy in last 6 months * Received live, inactivated or subunit virus vaccine or a bacterial vaccine within last 4 weeks * Intolerance or hypersensitivity to vaccines or vaccine components or has a drug or food allergy or allergic disease requiring medication

Locations (1)

Clinical Research Services Turku (CRST) Oy

Turku, Finland

Outcomes

Primary Outcomes

Incidence and severity of treatment-emergent adverse events (safety and tolerability)

Adverse events will be assessed by frequency and criteria for severity (mild, moderate or severe)

Time frame: Throughout the 32 weeks of the study

Secondary Outcomes

Development of neutralizing antibodies to coxsackie B virus (immunogenicity, efficacy)

Proportion of responders (ie, those that seroconvert or have at least a 4-fold increase in neutralizing antibody titers to any of the coxsackie B virus strains as measured by plaque reduction assay using serial serum dilutions)

Time frame: Days 1, 29, and 57 and Weeks 12 and 32

Titer of antibodies to coxsackie B virus (immunogenicity, efficacy)

Mean and peak geometric mean serum IgG titers of antibodies against any of the coxsackie B virus strains, measured by ELISA

Time frame: Days 1, 29 and 57 and weeks 12 and 32

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.